MMS, IFA, and MMS+IFA Supplementation in Pregnant Women

June 27, 2026 updated by: Sher Wali Khan, Sindh Institute of Child Health and Neonatology

Comparative Effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA), and Combined MMS+IFA on Maternal Hemoglobin Levels and Neonatal Outcomes Among Pregnant Women: An Open-Label Randomized Controlled Trial

This study aims to compare the effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA) supplementation, and combined MMS+IFA supplementation among pregnant women. Maternal anemia and micronutrient deficiencies are common during pregnancy and can adversely affect both maternal and neonatal health outcomes.

A total of 402 pregnant women with gestational age of 20 weeks or less will be randomly assigned to receive MMS, IFA, or combined MMS+IFA supplementation. Participants will be followed throughout pregnancy until delivery. Maternal hemoglobin levels, maternal compliance with supplementation, and neonatal outcomes including birth weight, preterm birth, APGAR scores, and congenital anomalies will be assessed.

The findings of this study will provide evidence to guide antenatal nutrition policies and practices in Pakistan.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Maternal micronutrient deficiencies remain a major public health concern in low- and middle-income countries, including Pakistan. Iron deficiency anemia, along with deficiencies of folate, vitamin D, vitamin B12, zinc, iodine, and other micronutrients, contributes substantially to adverse maternal and neonatal outcomes. Although routine Iron-Folic Acid (IFA) supplementation is recommended during pregnancy, it may not adequately address the broader spectrum of micronutrient deficiencies commonly observed among pregnant women.

Multiple Micronutrient Supplementation (MMS) has emerged as a comprehensive alternative that includes iron, folic acid, and additional essential vitamins and minerals required during pregnancy. Evidence from randomized controlled trials and systematic reviews suggests that MMS may improve selected neonatal outcomes; however, evidence regarding maternal hemoglobin improvement and compliance remains inconsistent across settings. Furthermore, limited data are available from Pakistan comparing MMS, IFA, and combined MMS+IFA supplementation.

This study is a three-arm, parallel-group, open-label randomized controlled trial conducted at the antenatal clinics of the Sindh Institute of Child Health and Neonatology (SICHN) in Karachi and Jamshoro, Pakistan. A total of 402 eligible pregnant women with gestational age ≤20 weeks and baseline hemoglobin ≥10 g/dL will be enrolled and randomized in a 1:1:1 ratio to receive either MMS, IFA, or combined MMS+IFA supplementation.

Maternal hemoglobin concentration will be measured at baseline, 28 weeks gestation, and 36-37 weeks gestation or delivery. Maternal compliance will be assessed using pill counts and self-reported supplement intake. Neonatal outcomes including birth weight, low birth weight, preterm birth, APGAR scores, and congenital anomalies will be evaluated at delivery.

The study aims to compare the effectiveness of MMS, IFA, and MMS+IFA supplementation on maternal hemoglobin levels, neonatal outcomes, and maternal compliance. Findings from this study will contribute to strengthening evidence-based antenatal nutrition policies and maternal health programs in Pakistan.

Study Type

Interventional

Enrollment (Estimated)

402

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women aged 18 years or older
  • Gestational age ≤20 weeks at enrollment
  • Singleton pregnancy
  • Hemoglobin concentration ≥10 g/dL at baseline
  • Willing and able to provide informed consent
  • Willing to comply with study procedures and follow-up visits

Exclusion Criteria:

  • Severe anemia requiring injectable treatment (hemoglobin <7 g/dL)
  • Pre-existing diabetes mellitus
  • Pre-existing hypertension
  • Renal disease
  • Current therapeutic iron or micronutrient supplementation beyond routine antenatal supplementation
  • Known fetal congenital anomalies
  • Any medical condition that, in the opinion of the investigator, would interfere with study participation or outcome assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MMS
Multiple Micronutrient Supplementation (MMS) containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy.
Dietary supplement: Multiple Micronutrient Supplementation (MMS)
WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy
Experimental: MMS + IFA
Combined Multiple Micronutrient Supplementation (MMS) and Iron-Folic Acid (IFA) supplementation administered daily during pregnancy. Total iron and folic acid intake will remain within safe WHO-recommended limits
Dietary supplement: Multiple Micronutrient Supplementation (MMS)
WHO-standard multiple micronutrient supplement containing iron, folic acid, zinc, iodine, vitamins A, D, C, and B-complex vitamins administered daily during pregnancy
Dietary supplement: Iron-Folic Acid (IFA)
Iron 60 mg and folic acid 400 µg administered daily during pregnancy.
Active Comparator: IFA
Dietary supplement: Iron-Folic Acid (IFA)
Iron 60 mg and folic acid 400 µg administered daily during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Hemoglobin Concentration
Time Frame: Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery
Maternal hemoglobin concentration measured using complete blood count (CBC) and compared between study groups.
Baseline, 28 weeks gestation, and 36-37 weeks gestation or at delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth Weight
Time Frame: At birth
Neonatal birth weight measured in grams within one hour of birth.
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sindh Institute of Child Health and Neonatology

Investigators

  • Principal Investigator: Rozina Feroz Ali, MBBS, MSC, Sindh Institute of Child Health and Neonatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 25, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

January 25, 2027

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SICHN/IRB-011/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At the time of study registration, no final decision has been made regarding the sharing of individual participant data (IPD). Any future data-sharing plan will be determined in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable regulatory requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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